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global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.

global®: fertilization, embryo culture and transfer medium

The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "global®: fertilization, embryo culture and transfer medium." It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

This document is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices. It does not elaborate on the specific performance studies, acceptance criteria, or statistical details typically found in a clinical study report or a more comprehensive section of a 510(k) submission.

Therefore, I cannot extract the requested information from the provided text.

To answer your request, I would need a document that includes sections like:

• Performance Data / Clinical Data: Details on studies conducted.
• Acceptance Criteria: Specific thresholds for device performance.
• Study Design: Information on sample size, data provenance, ground truth establishment, etc.
• Results: Reported device performance metrics.

In summary, none of the requested information (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, ground truth type, training set sample size, training set ground truth method) is present in the provided FDA letter.

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